26 May 2015
CVRx® Barostim Therapy® for Heart Failure Clinical Trial Results Presented in the Late-Breaking Clinical Trial Session of the Heart Rhythm Society 2015 Annual Conference
Minneapolis – May 26, 2015 – CVRx, Inc., a private medical device company, announced that positive results from the ‘Barostim Therapy for Heart Failure’ randomized, controlled clinical trial were presented at the 2015 annual Scientific Sessions of the Heart Rhythm Society (HRS) in a Late-Breaking Clinical Trial Session. Results were presented by Dr. Michael Zile from the Medical University of South Carolina.
Safety and efficacy results comparing patients previously treated with Cardiac Resynchronization Therapy (CRT) to patients without CRT (no-CRT) were presented. At six months in the no-CRT group, Dr. Zile reported that Quality of Life scores significantly improved, six-minute hall walk distance and left ventricular ejection fraction significantly increased, and heart failure hospitalizations were significantly reduced in Barostim Therapy patients compared to controls. “The results of the study are remarkable”, Dr. Zile said. “These data are not sufficient to rule out a therapeutic effect in CRT patients, but the effect was more pronounced in patients without CRT.”
“The positive results from our randomized, controlled clinical trial were well-received at HRS”, said Nadim Yared, CEO and President of CVRx. “There is a significant unmet medical need for patients with advanced, chronic heart failure despite having received guideline-directed therapies, and in particular, for those patients who are not candidates for CRT.”
About Barostim Therapy™
CVRx completed a 146-patient randomized, controlled clinical trial to determine the performance of Barostim Therapy for patients suffering from chronic heart failure with advanced symptoms. Aggregate results were recently presented at the American College of Cardiology’s (ACC) Annual Scientific Session and simultaneously published in JACC-HF. Barostim Therapy was shown to be safe and significantly improved patient functional and exercise capability, as well as quality of life, when compared to optimal medical therapy. Barostim Therapy also significantly reduced the plasma biomarkers of heart failure severity and the burden of heart failure hospitalizations in patients with heart failure.¹
About Barostim neo™
Barostim neo is a second-generation device that uses CVRx-patented technology designed to trigger the body’s own natural blood flow regulation system to treat patients suffering from chronic heart failure. The therapy is also a treatment option for patients with resistant hypertension. The system electrically activates the baroreflex, the body’s natural mechanism to regulate cardiovascular function. By activating this afferent pathway, Barostim Therapy reduces sympathetic activity and increases parasympathetic activity, ultimately restoring sympatho-vagal balance.
Key unique benefits:
- The Barostim neo can be turned on and off to demonstrate acute results
- It can be adjusted to meet each patient’s individual therapy needs
- It is a reversible treatment, the therapy can be turned off
- It provides 100 percent adherence to treatment by continuously activating the baroreflex
- It is compatible with and complementary to implantable cardiac rhythm management devices²
About Heart Failure
Heart failure is a serious condition that impairs heart function, resulting in shortness of breath, exercise intolerance and fluid retention. In the United States, heart failure is estimated to affect 5.1 million adults.3 Overall, heart failure is associated with a four-fold increased risk of death and a six to nine times increased risk of sudden cardiac death. The direct and indirect costs of heart failure are estimated to be $32 billion in the United States in 2013.3
About CVRx, Inc.
CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis, Minnesota. The company has developed the second-generation Barostim neo, a minimally-invasive implantable system and the only device CE Marked for the separate indications of heart failure and resistant hypertension. Barostim neo is commercially available in over 20 countries and under clinical evaluation for the treatment of heart failure, hypertension, and chronic kidney disease in the United States. It is now MR Conditional, or safe for use under specified conditions in Europe. The company’s Barostim neo legacy™, holds Humanitarian Device Exemption (HDE) approval from the FDA, deeming it safe for use in hypertensive patients who were responders to the firstgeneration Barostim Therapy with Rheos Carotid Sinus Lead System.
1. Abraham W, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction, JACC: Heart Failure (2015), doi: 10.1016/j.jchf.2015.02.006
2. Madershahian N, et al. Baroreflex activation therapy in patients with preexisting implantable cardioverter-defibrillator: Compatible, complementary therapies. Europace Feb, 2014
3. Go A, Heart Disease and Stroke Statistics. American Heart Association – 2013 Update. Circulation 2013;127:e6-e245
CAUTION: Barostim neo® is an investigational device and is limited by United States law to investigational use. Exclusively for Clinical Investigations for the treatment of heart failure and resistant hypertension in Canada.
CVRx, HOPE4HF, Barostim neo and Barostim Therapy are trademarks of CVRx, Inc. registered in the United States Trademark Office.
© CVRx, Inc. 2015. All rights reserved.